Amerigo Scientific offers production services for custom 14C-labeled active pharmaceutical ingredients (APIs). With state-of-the-art laboratories equipped with advanced equipment and experienced synthetic and purification chemists, our service can meet the production needs of almost any custom 14C-labeled compound for clinical trials.
According to our clients' specific requirements, customized synthesis process is in strict accordance with GMP guidelines. 14C-labeled compounds applicable for either human balance studies in Phase I or ultra-low dose micro-dose trials (Phase 0) are synthesized by experienced radiochemists. Each batch of production is carried out in dedicated cleanroom laboratories, using validated processes, complete batch records, and strict contamination control measures.
Small-scale non-GMP batch is preformed to optimize the route and ensure success, before scaling up to the GMP batch, thereby minimizing risks and delays in the project.
GMP Batch Production
Amerigo Scientific provides GMP production services that are conducted by experienced and trained laboratory staff.
Figure 1. GMP production processes
Non-GMP Batch Production
Before the full-scale GMP production of 14C-labeled APIs, a non-GMP batch is usually prepared first to test the planned production steps. Based on the production information of the technical batch, the detailed master batch records used in the GMP production process will be ultimately determined.
Before commencing GMP production, preparing a technical batch offers numerous benefits, including:
- Ensuring that the planned production process can be completed smoothly
- Demonstrating that we can meet the proposed GMP specification requirements
- Addressing any potential issues that may arise during synthesis, purification, or analysis process before full-scale GMP production
- Drafting and revising the main batch records
- Conducting stability studies on the technical batch products to determine the stability of the 14C-labeled API and the appropriate storage condition
Please contact us to discuss your customized production needs for GMP 14C-labeled API.
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